Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry

2023P000494

A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease

2023-07-16

2028-06-01

2028-06-01

Recruiting

500

Inclusion Criteria: * o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease * Patient has evidence of cognitive impairment on neuropsychological testing * Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement * Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease * Amyloid PET imaging positive * CSF p-Tau/Abeta42 ration \>0.023 and ABeta42 \< 1027\*\* * 3T MRI in past 6 months * Patient has a care partner * Patient under the care of an appropriate BI-Lahey amyloid clinic * Patient is on a stable medication regimen Exclusion Criteria: * o Recent stroke or suspected TIA in the past year * Pregnancy * Active autoimmune or immunological disease * Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives * Bleeding disorder with Plts \< 50,000 or INR \> 1.5 * On warfarin, heparin, or DOAC * On dual antiplatelet therapy * Non Alzheimer disease cause of dementia/MCI * ApoE e4 homozygote

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '30 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2023-09-28